Quality Control
Quality control starts with product quality and customer needs, with the accuracy, reliability, and effectiveness of testing results as its foundation. Cnpair has established a comprehensive quality control system covering the full product lifecycle. We follow applicable international and national standards for quality management and analytical method validation. For quality control methods, Cnpair conducts scientific validation with reference to ICH Q2(R2) and relevant analytical method validation guidelines of the Chinese Pharmacopoeia, evaluating key parameters including accuracy, precision, specificity, linearity, and stability to ensure that analytical methods are scientifically sound, reliable, and fit for product quality evaluation.
Equipment & Facilities
Adequate and Compliant Equipment & Facilities
Full Lifecycle Equipment Management
Multi-Dimensional Performance Validation
Potency Control
Stability Control
Batch-to-Batch Consistency
Multi-Platform Validation
Appearance Control
Concentration Control
Purity Control
Potency Control
Potency is one of the most critical indicators of the functional performance of biological raw materials. Cnpair evaluates product potency and biological activity through different assay formats and serial dilution conditions, focusing on reactivity, functional performance, and stability under practical application conditions.
Stability Control
Product stability is systematically evaluated through accelerated stability studies, repeated freeze-thaw testing, retention sample management, and ongoing verification, providing comprehensive assessment of product performance under different storage and handling conditions.
Batch-to-Batch Consistency
Cnpair conducts systematic comparison and performance verification across multiple production batches, with batch-to-batch variation controlled within ≤15%, supporting consistent product quality and performance.
Multi-Platform Validation
Based on customers’ actual application requirements, product performance is evaluated across different testing platforms, including POCT and CLIA, to assess raw material compatibility, performance, and stability across different assay systems.
Appearance Control
Standardized appearance specifications are established for product quality control. Products are rigorously inspected to ensure a clear solution with no visible particles, precipitation, or turbidity, meeting predefined quality requirements.
Concentration Control
Three independent analytical methods — UV spectrophotometry, BCA assay, and Bradford assay — are used to determine product concentration. Results are cross-checked against one another to enhance the accuracy and reliability of concentration measurement.
Purity Control
Product Purity Control: Product purity is strictly controlled at ≥90%, with SDS-PAGE and other analytical methods used to evaluate product purity and homogeneity, ensuring high-purity raw materials meet application requirements.
Full-Process Traceability
From Critical Raw Materials to Product Delivery, Every Quality Step Is Traceable. Cnpair has established a comprehensive quality traceability system covering raw materials, production processes, finished-product quality control, warehousing, logistics, and customer delivery.
Supply Chain Management
Cnpair applies standardized supplier management and diversified sourcing for critical materials, with key parameters such as microbial limits, culture performance, and purification column capacity evaluated according to intended use, ensuring quality and full traceability.
Production Management
Cnpair utilizes an ERP production management system to manage production planning, batch information, and key manufacturing processes digitally, enabling standardized, systematic, and traceable production management.
Batch Quality Traceability
A comprehensive batch traceability system links each production batch with its corresponding manufacturing information, quality control results, and original quality records, ensuring that quality data is complete, accessible, and traceable throughout the product lifecycle.
Retention Sample Management
Cnpair has established a standardized retention sample library for systematic storage and management of samples from different production batches. Retention samples support subsequent stability evaluation, quality review, and ongoing verification, enabling continuous monitoring of product quality.
Warehousing Management
Standardized procedures are implemented for product receiving, storage, inventory status verification, and release. Appropriate storage conditions are managed according to product characteristics to help maintain product quality throughout the warehousing process.
Logistics Management
Professional transportation solutions are developed according to product characteristics and specific storage requirements. Protective packaging, cold-chain temperature control, shipment tracking, and delivery verification are implemented throughout the logistics process.